EMMA™ mmHgRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07350046131750), received between Nov 19, 2020 and Sep 9, 2022 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2022High Readings; High Readings

  THE CUSTOMER REPORTED THE DEVICE MEASUREMENTS WERE TOO HIGH, EVEN AFTER PERFORMING THE ZEROING PROCEDURE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396689 ↗
• MalfunctionAug 25, 2022Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THE DEVICE WILL SWITCH OFF AUTOMATICALLY AFTER 2 TO 3 MINUTES AFTER POWER ON. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15299017 ↗
• MalfunctionMay 19, 2022No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED NO SOUND FROM THE SPEAKER. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14440176 ↗
• MalfunctionDec 30, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE EMMA WAS INACCURATE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122380 ↗
• MalfunctionDec 30, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE EMMA WAS INACCURATE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122370 ↗
• MalfunctionDec 23, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THE MEASUREMENT VALUES ARE TOO LOW. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13082146 ↗
• MalfunctionNov 24, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE DEVICE READS A CO VALUE BETWEEN 15% AND 20% DIFFERENT COMPARED WITH A BLOOD SAMPLE MEASUREMENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872318 ↗
• MalfunctionNov 24, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE DEVICE READS A CO VALUE BETWEEN 15% AND 20% DIFFERENT COMPARED WITH A BLOOD SAMPLE MEASUREMENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872292 ↗
• MalfunctionNov 10, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE DEVICE WAS OUT OF TOLERANCE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790496 ↗
• MalfunctionNov 10, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE DEVICE WAS OUT OF TOLERANCE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790455 ↗
• MalfunctionOct 15, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THE DEVICE GAVE INACCURATE READINGS, LOW CO2. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643495 ↗
• MalfunctionOct 1, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE CUSTOMER REPORTED THE DEVICE DETECTOR LENS IS RECESSED AND SHUT DOWN AUTOMATICALLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565623 ↗
• MalfunctionSep 30, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE DETECTOR LENS IS RECESSED. SOMETIME IS ABLE TO USE BUT NOT SURE IF THE VALUE IS ACCURATE UNDER THIS ERROR. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558487 ↗
• MalfunctionSep 17, 2021Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE DEVICE WORKS INTERMITTENTLY, DOES NOT RECOGNIZE WHEN ADAPTER IS MOVED. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12492447 ↗
• MalfunctionAug 16, 2021High Readings; High Readings

  THE CUSTOMER REPORTED THAT THE EMMA PROVIDED HIGH VALUES. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328315 ↗
• MalfunctionJun 24, 2021Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE DEVICE STOPS SHOWING THE RESPIRATORY RATE IN THE MIDDLE OF SURGERY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12058188 ↗
• MalfunctionApr 6, 2021High Readings; High Readings

  THE CUSTOMER REPORTED THE DEVICE IS READING HIGHER THAN IT SHOULD. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624994 ↗
• MalfunctionNov 19, 2020Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE DEVICE IS PROVIDING 50 POINTS DIFFERENCE WHEN COMPARED TO BLOOD SAMPLE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10868092 ↗